Multi-Layer Odor Barrier Tube, and Combination Odor Barrier Tube and Odor Barrier Collection Bag

ABSTRACT

A catheter tube for a fecal drainage system has a first layer and a second layer. At least one of the first and second layers is an odor barrier layer of material and at least one of the first and second layers is a thermoplastic elastomer material.

RELATED APPLICATION DATA

This application is a continuation under 37 C.F.R. §1.53(b) and 35U.S.C. §120 of U.S. patent application Ser. No. 12/238,584 of the sametitle filed on Sep. 26, 2008, which claimed priority benefit of U.S.provisional application Ser. No. 60/976,214 filed Sep. 28, 2007.

BACKGROUND

1. Field of the Disclosure

This disclosure is generally directed to medical tubing and, morespecifically, to multi-layered tubing having odor barrier propertiessuitable for use as catheter tubing for fecal drainage systems, and acombination odor barrier tube and odor barrier collection bag.

2. Background

Catheter tubes for fecal drainage systems are designed to facilitateflow of fecal matter, with the fecal matter typically draining into acollection bag. A catheter tube can include a lubricious coating on aninterior to facilitate movement of fecal matter. While various materialshave been used to form the walls of a catheter tube, no catheter tubesfor fecal drainage systems are known that include integral odor barrierproperties. One reason for the lack of catheter tubes having odorbarrier properties is that odor barrier materials are understood to betoo stiff and not suitable for catheter tubing applications. Byproviding a multi-layer catheter tube with at least one odor barrierlayer, the catheter tube can reduce or eliminate exposure of thepatient, caregivers, and other persons in the vicinity of the patient tounpleasant odors.

Fecal drainage systems are frequently employed in combination withenema, lavage, or other irrigation techniques to loosen stool in therectum of a patient. As a result, water or other liquid is likely totravel through the catheter tube with fecal matter.

SUMMARY

In preferred embodiments of the present disclosure, the catheter tubingfor a fecal drainage system is made of at least two layers of differentmaterials. The layers are preferably co-extruded, or one layer may beextruded and one or more subsequent layers may subsequently be appliedby extrusion over the first layer, but alternately, the layers may beformed as a generally flat laminate sheet that is rolled into a tubularshape, then sealed along a seam, for example using sealing technology,such as heat sealing or RF sealing, using adhesive sealing, orultrasonic welding. In order to increase durability, at least one of thelayers of the flat laminate sheet that is then rolled into a cylindercan be a semi-rigid mesh or scrim material.

Another desirable feature of a catheter tube for a fecal drainage systemis minimal wall thickness. The multi-layer odor barrier catheter tube ofthe present disclosure can be manufactured with a total wall thicknessin the range of about 10 mil to about 60 mil.

The odor barrier layer may be a resin, preferably a polyamide, and mostpreferably nylon 666. The odor barrier layer may include an additive inthe form of a modifier for reduced modulus, preferablyethylene-ethylacrylate-maleic anhydride terpolymer (commerciallyavailable as Lotader® 4720, from Arkema, Inc. of Philadelphia, Pa.). Theodor barrier layer is preferably the outermost layer, or outer skin, ofthe catheter tube.

The odor barrier layer of the catheter tube preferably has a thicknessof 3 mil or less, and the thickness of the odor barrier is preferablyless than 30% of the total tube wall thickness. The odor barrier layerpreferably has a kinetic coefficient of friction less than 0.5.

A second layer of the catheter tube may be a resin or resin blend,preferably having a modulus of elasticity less than 100,000 psi (2%secant) when measured according to ASTM D882.

A third layer forming the innermost layer or inner skin of the cathetertube may also be employed. The third or innermost layer preferably has alow kinetic coefficient of friction, preferably less than 0.5. The lowkinetic coefficient of friction may be an inherent property of a drymaterial of which the third layer is formed. Lubricity is a beneficialfeature of the innermost layer of the catheter tube to promote orfacilitate flow of fecal matter through the catheter tube. In order toachieve the desired lubricity of the innermost surface of the cathetertube, the inner layer of the multi-layer odor barrier tube of thepresent disclosure may be made of a copolymer of ethylene, preferably anethylene vinylacetate copolymer (EVA) with an added slip agentconcentrate, such as 10090 Slip PE MB, having a concentration of 5%Erucamide, available from Ampacet of Tarrytown, N.Y., to lower thecoefficient of friction. Preferably, the slip agent concentrate is onlyabout 2% of the overall composition of the innermost layer of thecatheter tube, so the effective concentration of the Erucamide is about0.1%.

In light of the likely presence of water or other liquid travelingthrough the catheter tube with the fecal matter, as an alternative to anEVA copolymer, a hydrophilic polymer that becomes lubricious in contactwith water, preferably polyethyleneoxide or polyvinylalcohol, may beused as the inner layer of the multi-layer odor barrier catheter tube.

If the collection bag into which the catheter tube drains lacks odorbarrier properties, unpleasant odors can escape the collection bag,thereby negating the odor barrier benefits achieved by the odor barriercatheter tube. It is therefore desirable for the odor barrier tube todrain into a collection bag that itself has odor barrier walls.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a first embodiment of a multi-layer odorbarrier catheter tube of the present disclosure;

FIG. 2 is an axial cross-sectional view, taken along lines 2-2 of FIG.1;

FIG. 3 is an axial cross-sectional view, similar to FIG. 2, of a secondembodiment of a multi-layer odor barrier catheter tube of the presentdisclosure, wherein tie layers are provided between the first and secondlayers, and between the third and fourth layers;

FIG. 4 is a perspective view of a heat-laminated film employed in amethod of manufacture of a multi-layer odor barrier catheter tube of thepresent disclosure;

FIG. 5 is a perspective view of the heat-laminated film of FIG. 4,rolled into a cylindrical shape and sealed along a seam;

FIG. 6 is a perspective view of a heat-laminated film similar to that ofFIG. 4, and including a flexible scrim layer;

FIG. 7 is a perspective view of the heat-laminated film of FIG. 6,rolled into a cylindrical shape and sealed along a seam;

FIG. 8 is a front view of a combination of a multi-layer odor barriercatheter tube of the present disclosure in combination with a drainablecollection bag having odor barrier walls;

FIG. 9 is a front perspective view of a combination of a multi-layerodor barrier catheter tube of the present disclosure in combination witha closed, single-use collection bag having odor barrier walls; and

FIG. 10 is a front perspective view of a multi-layer odor barriercatheter tube of the present disclosure having only two layers.

DETAILED DESCRIPTION OF THE DISCLOSURE

With reference to the drawings, in a first embodiment of a multi-layerodor barrier catheter tube 10 of the present disclosure connectable at afirst end to a patient-proximal internal section, and/or a trans-analsection of a rectal catheter (not shown), and at a second end,connectable to a waste collection bag or to a disposal receptacle (e.g.,a bedpan or toilet (not shown)) is provided. At least one of the layersof the multi-layer catheter tube 10 is constructed of materialsresistant to transmission of fecal and flatus gasses.

A first layer 12 of the catheter tube 10 defines the external surface 14of the catheter tube 10. The first layer 12 is preferably comprised ofone or more materials that possess a relatively low coefficient offriction, most preferably less than 0.5, so as to reduce drag of thecatheter tube 10 against a patient's skin, and against items surroundingthe patient, including a hospital gown, bed sheets, chair or otherobjects in the patient's immediate vicinity. The low coefficient offriction of the external surface 14 of the catheter tube 10 alsofacilitates “milking” the fecal matter down the length of the cathetertube 10. The material or materials defining the first layer 12 of thecatheter tube 10 include an odor barrier resin. In other embodimentswithin the scope of the present disclosure, the odor barrier resin maybe employed as a layer of the catheter tube 10 other than the firstlayer 12 defining the outside surface 14.

A suitable material for the first layer 12 of the catheter tube 10 ofthe present disclosure is a polyamide, most preferably nylon 666. Amodifier may be added to achieve a reduced modulus, preferablyethylene-ethylacrylate-maleic anhydride terpolymer, commerciallyavailable as Lotader® 4720 from Arkema, Inc. The external surface 14 ofthe first layer 12 is preferably a surface that will receive inks suchas permanent or semi-permanent markers, and retain such markings thereonwithout smudging or wiping off, to facilitate receiving instructions,patient data, collection bag change data, dates of indwell or intendedremoval of the catheter tube, and the like.

An intermediate layer 16 of the multi-layer catheter tube 10 preferablycomprises a resin or resin blend having a modulus of elasticity lessthan 100,000 psi (2% secant) when measured according to ASTM D882. Theresin used as the material forming the intermediate layer 16 ispreferably a thermoplastic elastomer, most preferably polyurethane or apolyurethane blended with another thermoplastic elastomer, having apreferred modulus less than 40,000 psi (2% secant). As described in moredetail below, more than one layer of material may be providedintermediate the first layer 12 defining the external surface 14 of thecatheter tube 10 and a third layer 18 defining an internal surface 20 ofthe catheter tube 10. If only a first layer 12 and a low modulus layerare provided, the layer referenced herein as the intermediate layer 16may instead be the inner-most layer of the catheter tube 10, as shown inFIG. 10.

Depending on the compatibility of the materials of adjacent layers ofthe multi-layered catheter tube 10, as shown in FIG. 3, a tie layer 22,such as a Bynel® tie material available from DuPont, may be employedbetween adjacent layers to improve adhesion of the adjacent layers toone another.

Another layer 18 of the multi-layer catheter tube 10, defining theinternal surface 20 of the catheter tube 10, is preferably made of oneor more materials that possess a relatively low coefficient of friction,preferably less than 0.5, to allow stool and bowel discharge to floweasily along the internal length of the catheter tube 10 for collectionand/or disposal. A suitable material for the layer 18 is a copolymer ofethylene, most preferably an ethylene-vinylacetate copolymer (EVA) withan added slip agent (such as 10090 Slip PE MB, having a concentration of5% Erucamide, available from Ampacet of Tarrytown, N.Y.), wax, PTFE, orother friction-reducing additive to achieve a low coefficient offriction. Such additives may also be used to lower the coefficient offriction of the first layer 12 defining the external surface 14 of thecatheter tube 10. As an alternate to the material or materials definingthe layer 18 of the catheter tube 10 inherently possessing a lowcoefficient of friction, a hydrophilic polymer that becomes lubriciousin contact with water, preferably polyethyleneoxide or polyvinylalcohol,may be used as the innermost layer of the multi-layer odor barriercatheter tube 10. This may be accomplished by the layer 18 having acapability of anchoring hydrophilic materials thereto, and thensupplying an additional hydrophilic layer, such as by co-extrusion,internally of the layer 18. As a further alternate, the layer 18 mayitself be formed entirely of a hydrophilic polymer, and anchoreddirectly to intermediate layer 16, provided that there is adequateadhesion between the hydrophilic layer 18 and the intermediate layer 16.

The multi-layer catheter tube 10 of the first embodiment of the presentdisclosure may be manufactured by co-extrusion. In order to maximizetube softness and flexibility, it is desirable for the odor barrierlayer of the catheter tube 10 to be thin, preferably in a range of lessthan about 2 to about 3 microns. However, it is not possible withconventional co-extrusion processes to co-extrude a sufficient length ofcatheter tubing having such a thin odor barrier layer.

As an alternative to co-extrusion, as shown in FIGS. 4-5, the layers ofthe catheter tube 10 may be formed into a flat or substantially flatheat-laminated film 24, having two parallel edges 26, 28 that are rolledtoward one another, brought into register with one another, and sealedto one another, such as by heat sealing, RF sealing, adhesive sealing,or ultrasonic welding, to form a cylinder, with the first layer 12 ofthe film 24 defining an external surface 14 of the cylinder and thethird layer 18 defining an internal surface 20 of the cylinder. Aleading end 30 and a trailing end 32 of the heat-laminated film 24 areleft open, forming first and second ends 34, 36 of the catheter tube 10.Optionally, tie layers (represented by broken lines in FIG. 4) may beprovided to enhance bonding between the first and second layers, and/orbetween the second and third layers 16, 18. The first, second and thirdlayers 12, 16, 18 of the catheter tube 10 are preferably clear ortranslucent. The sealed edge or seam 38 may be visible, and canadvantageously provide a medical caregiver with a visible indicator ofany kinking or twisting of the catheter tube.

The total cumulative wall thickness of the multi-layer catheter tube 10is preferably in the range of about 10 mil to about 40 mil, and morepreferably in a range of about 25 mil to about 35 mil, with thethickness of the odor barrier layer (e.g., the first layer 12) making upless than about 30% of the total wall thickness of the catheter tube 10.

Adjustments may be made to process conditions under which the layers ofthe multi-layer catheter tube of the present disclosure are co-extrudedor heat laminated to reduce the coefficient of friction of one or moreof the layers.

In another embodiment, shown in FIGS. 6-7, in order to providereinforcement and avoid kinking or twisting of a catheter tube 40, amesh or flexible scrim layer 42 may be included as an additional layerintermediate the first layer 12 and third layer 18 of the multi-layercatheter tube 40. The scrim layer 42 also provides the catheter tube 40with shape memory, permitting the catheter tube 40 to collapse andrecover to its cylindrical shape without any permanent deformation.Materials other than a scrim layer 42 may be utilized instead of or inaddition to the scrim layer 42 to enhance structural integrity of thecatheter tube 40, such as polymeric materials.

The material(s) forming the internal and/or external surfaces of themulti-layer catheter tube of the present disclosure preferablyfacilitate attachment and assembly of the catheter tube to peripheralcomponents of fecal drainage and management systems, such as the BowelManagement System available from Hollister Incorporated of Libertyville,Ill., the assignee of the present disclosure. As such systems areintended for long-duration use, on the order of about twenty-nine days,it is advantageous to employ materials that will easily form a reliablebond, by adhesive and/or heat, between the catheter tube and theperipheral components, such as internal or external silicone balloons,catheter connections, such as to a collection bag or to a catheter tubeextension, or plastic or metal ports, such as ports for providingendoscope access or for sampling fecal matter directly from the cathetertube, for the entire duration of use of the catheter.

As noted above, the advantages achieved by the odor barrier propertiesof the catheter tubes of the present disclosure would be negated, orsignificantly diminished, if fecal or flatus gasses could be transmittedthrough one or more walls of a collection bag 44 (see FIG. 8) to whichthe catheter tube 10 is connected. It is therefore desirable to use themulti-layer odor barrier catheter tube 10 in combination with acollection bag 44 having odor barrier walls. For example, each of thewalls of the collection bag may include a barrier layer film such as theone disclosed in U.S. Pat. No. 7,270,860.

The odor barrier collection bag may be a drainable collection bag 44,having a drainage tube 46 with a drainage tube stopper 48 and a cap 50for capping a catheter tube connection port 52, as shown in FIG. 8.Alternately, the odor barrier collection bag may be a so-called “closed”collection bag 54, as illustrated in FIG. 9. A closed collection bag 54is intended for single use, and preferably includes an integral vent 56with a deodorizing filter 58.

While certain embodiments of multi-layer odor barrier catheter tubes,combinations of multi-layer odor barrier catheter tubes and odor barriercollection bags, and methods of manufacturing multi-layer odor barriercatheter tubes are disclosed herein, the appended claims are notintended to be limited thereto. Variations can be made to the disclosedembodiments that are still within the scope of the appended claims,literally or under the doctrine of equivalents.

What is claimed is:
 1. A catheter tube for a fecal drainage system, thecatheter tube comprising: a first layer; and a second layer, wherein atleast one of the first and second layers is an odor barrier layer ofmaterial and at least one of the first and second layers is athermoplastic elastomer material.
 2. The catheter tube of claim 1,wherein the first layer is formed of a different material than thesecond layer.
 3. The catheter tube of claim 1, wherein the first layerdefines an external surface of the catheter tube and is relativelythinner than the second layer, the first layer having a coefficient offriction less than about 0.5.
 4. The catheter tube of claim 1, whereinthe first layer defines an external surface of the catheter tube and thesecond layer is the odor barrier layer of material.
 5. The catheter tubeof claim 4, wherein the first layer has a thickness in a range of lessthan about 2 mil to about 3 mil and is the thermoplastic elastomermaterial.
 6. The catheter tube of claim 5, wherein the second layer isadjacent the first layer and is thicker than the first layer and has amodulus of elasticity less than 100,000 psi when measured according toASTM D882.
 7. The catheter tube of claim 4, further comprising a thirdlayer defining an internal surface of the catheter tube, the secondlayer positioned between the first and third layers.
 8. The cathetertube of claim 7, wherein the third layer has a coefficient of frictionless than about 0.5.
 9. The catheter tube of claim 7, wherein at leastone of the first and third layers is the thermoplastic elastomermaterial.
 10. The catheter tube of claim 7, wherein both the first andthird layers are a thermoplastic elastomer material.
 11. The cathetertube of claim 7, wherein the third layer is capable of anchoring ahydrophilic coating layer, the hydrophilic coating layer defining theinternal surface of the catheter tube.
 12. The catheter tube of claim 1,wherein a total wall thickness of the catheter tube is in a range ofabout 10 mil to about 40 mil.
 13. The catheter tube of claim 1, whereinat least one of the first and second layers of the catheter tubeincludes a flexible scrim layer.
 14. The catheter tube of claim 1,further comprising at least one tie layer between at least the first andsecond layers of the catheter tube.
 15. The catheter tube of claim 1,wherein the at least one of the first and second layers that is the odorbarrier layer of material has a thickness that is less than 30% of atotal wall thickness of the catheter tube.
 16. The catheter tube ofclaim 1, wherein the catheter tube is part of a fecal drainage systemthat includes a collection bag having odor barrier walls.
 17. A cathetertube for a fecal drainage system, the catheter tube comprising: a firstlayer defining an external surface of the catheter tube and formed of athermoplastic elastomer material; a second layer formed of a materialincluding polyamide with odor barrier properties; and a third layerdefining an internal surface of the catheter tube and formed of athermoplastic elastomer material, the second layer being an intermediatelayer positioned between the first and third layers.
 18. The cathetertube of claim 17, wherein the second layer is a Nylon material layerdirectly adjacent and connected to both the first and third layers. 19.The catheter tube of claim 17, wherein the catheter tube is part of afecal drainage system that includes a collection bag having odor barrierwalls.
 20. The catheter tube of claim 1, wherein the first and secondlayers are coextruded with one another having a generally cylindricalshape.
 21. A fecal drainage system comprising: a collection bag havingodor barrier walls; and a catheter tube connected to the collection bag,the catheter tube including a first layer; and a second layer coextrudedwith the first layer, wherein at least one of the first and secondlayers is an odor barrier layer of material and at least one of thefirst and second layers is a thermoplastic elastomer material.
 22. Thefecal drainage system of claim 21, wherein the catheter tube furthercomprises a third layer coextruded with the first and second layers, andwherein the second layer is an intermediate layer between the first andthird layers.
 23. The fecal drainage system of claim 22, wherein thesecond layer includes a polyamide and defines the odor barrier layer ofmaterial.
 24. The fecal drainage system of claim 23, wherein the firstand third layers are a thermoplastic elastomer material.
 25. The fecaldrainage system of claim 21, wherein the catheter tube has a generallycylindrical coextruded shape.